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Can enzyme capsules stop weight loss in pancreatic cancer?

NCT ID NCT06099119

NEW Symptom relief Sponsor: Hospital Clinico Universitario de Santiago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether pancreatic enzyme replacement therapy helps patients with unresectable pancreatic cancer maintain their weight. The trial enrolls 100 adults whose tumor sits in the head of the pancreas, has blocked the main pancreatic duct, and who have already lost at least 5% of their usual body weight. Half receive enzyme capsules with meals and snacks for six months alongside standard care, while the other half receive standard care alone for three months before starting enzymes. The main measure is weight change from the start to the end of the study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pancreatic enzyme replacement therapy with pancreatin capsules
What this could lead to
If it works, pancreatic enzyme supplements could become a standard add-on to help patients with advanced pancreatic cancer hold onto their weight and better tolerate treatment.
What could go wrong
This is a small, open-label trial, so results may not hold up in larger blinded studies. Enzyme supplements can cause stomach upset or allergic reactions, and weight change can be driven by many factors beyond enzyme levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer. 2. Tumour located in the head of the pancreas. 3. Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS). 4. Significant weight loss (≥5% of the usual body weight) at screening. 5. Life expectancy of at least six months at screening. 6. Signed informed consent to the study. Exclusion Criteria: 1. Hypersensitivity to pancreatin of porcine origin or to any of the excipients. 2. Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned. 3. Patients already on PERT. 4. Prior history of upper gastrointestinal or pancreatic surgery. 5. Short life expectancy (shorter than 6 months). 6. Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy). 7. Patients in whom a pancreatic stent has been placed. 8. Unsolved gastric outlet obstruction. 9. Unwillingness to participate in the study. 10. Inability to comply with the study visits and study protocol, whatever the reason.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unresectable pancreatic cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Istituto di Ricovero e Cura Carattere Scientifico San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Karolinska Institutet

    NOT_YET_RECRUITING

    Stockholm, 17177, Sweden

  • University Hospital of Santiago de Compostela

    RECRUITING

    Santiago de Compostela, A Coruna, 15706, Spain

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